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510(k) Data Aggregation

    K Number
    K150248
    Device Name
    ORL Video NasoPharyngo-Larngoscope
    Manufacturer
    JEDMED INSTRUMENT COMPANY
    Date Cleared
    2015-07-23

    (170 days)

    Product Code
    EQN
    Regulation Number
    874.4760
    Why did this record match?
    Product Code :

    EQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.
    Device Description
    This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.
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    K Number
    K132039
    Device Name
    ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
    Manufacturer
    JEDMED INSTRUMENT CO.
    Date Cleared
    2014-02-21

    (234 days)

    Product Code
    EQN
    Regulation Number
    874.4760
    Why did this record match?
    Product Code :

    EQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords.
    Device Description
    This flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.
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